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Recall of Philip Morris Cigarettes, May 1995-March 1996

Recall of Philip Morris Cigarettes, May 1995-March 1996

May 01, 1996

On May 26, 1995, Philip Morris USA* announced a voluntary recall
of 36 cigarette product lines (approximately 8 billion cigarettes)
because, during production, the company detected unusual tastes
and peculiar odors and identified methyl isothiocyanate (MITC)
in the cigarette filters. During June 6-8, 1995, public health
officials in Minnesota, Oregon, and Texas requested the assistance
of the Centers for Disease Control (CDC) in investigating consumer
health complaints associated with smoking Philip Morris cigarettes
near the time of the recall. This report summarizes CDC's ongoing
investigation, which suggests that prolonged cigarette smoking
caused most of the health complaints; in addition, the investigation
has not identified a distinguishing chemical characteristic of
the recalled cigarettes.

Reports of cases of illness near the time of the recall were identified
through passive surveillance by direct telephone calls to the
CDC. The CDC used a standardized form to interview persons who
reported illness and, when possible, collected cigarette samples.
To verify self-reported data, a medical records review was conducted.
Cigarettes included in the recall had been manufactured during
May 13-22. Philip Morris USA provided the CDC with samples of
recalled cigarettes (manufactured on May 19, 1995) and, for comparative
analyses, provided samples of cigarettes manufactured before (on
March 3, 1995) and after (on June 12, 1995) the recall.

Reports of Illness

During June-July 1995, the CDC received reports of illness from
72 persons in 27 states who had smoked Philip Morris cigarette
brands on or after May 13, 1995. The 72 persons comprised 36 men
and 36 women; the mean age of these persons was 40 years (range,
15 to 67 years). A total of 41 (57%) persons reported onsets of
illness before the recall, and 31 (43%) reported onsets after
the recall. Of the 72 persons, 51 (71%) reported no preexisting
health conditions; 42 (58%) reported experiencing serious health
problems from smoking near the time of the recall. A case definition
could not be developed because no common pattern of symptoms was
identified; however, the most frequently reported manifestation
was at least one respiratory or nasopharyngeal symptom (61 [85%]);
other frequently reported symptoms included headache (18 [25%]),
dizziness (15 [21%]), and ophthalmologic problems (15 [21%]).
A total of 59 (82%) persons sought medical treatment for their
symptoms; 14 (19%) were hospitalized.

All 72 persons reported smoking cigarettes manufactured by Philip
Morris the day they became ill. Most persons (43 [60%]) smoked
Marlboro brand cigarettes. The average duration of smoking was
20 years (range, < 1 to 45 years), and the average number of
cigarettes smoked per day was 23 (range, <1 to 50 cigarettes).

Medical Records Review

Because a case definition could not be specified, further investigation
was restricted to 29 persons who reported no preexisting health
conditions and who reported experiencing serious health problems
associated with smoking near the time of the recall. Of these
persons, medical records were obtained for 20. Based on review
of these records, the conditions most frequently diagnosed in
these persons near the time of the recall were pneumonia (four
persons), exacerbation of asthma (four), bronchitis (three), chronic
obstructive pulmonary disease (three), eosinophilic pneumonitis
(two), and laryngitis (two). The review suggested that most (18
[90%]) of these illnesses were associated with cigarette smoking,
preexisting medical conditions resulting from prolonged cigarette
smoking, or infectious agents.

Laboratory Analyses

The CDC analyzed cigarette samples using high-resolution gas chromatography/high-resolution
mass spectrometry. Methyl isothiocynate was detected in samples
of filter and samples of tobacco and paper obtained from prerecall,
recall, and postrecall cigarettes provided by Philip Morris. Levels
of MITC were higher in cigarettes packaged in hard packs than
in soft packs (eg, 102 vs 15 ng per filter, P < .01, N = 21
[14 hard packs and 7 soft packs]). Methyl isothiocyanate also
was detected in Philip Morris cigarettes produced at least 1 year
before the recall. Seven packs of cigarettes from five other manufacturers
were purchased at local stores in Atlanta; MITC was detected in
cigarettes from each of these packs.

Cigarettes obtained from Philip Morris were analyzed for the eight
compounds reported by Philip Morris** to have caused the taste
and odor problems. Of the eight compounds, three (butyric acid;
1,2-propanediol diacetate; and 2-ethylhexyl acetate) were detected
in prerecall, recall, and post-recall cigarettes; the other five
compounds were not detected. Compared with prerecall and post-recall
cigarettes, there was no distinctive increase in one or more of
these compounds in the recall cigarettes.

Cigarette samples also were analyzed to identify a unique chemical
profile that distinguished the recall cigarettes from the prerecall
or post-recall cigarettes. Analysis of volatile organic compounds
from the filter and from the tobacco and paper of these cigarettes
did not identify such a profile. In addition, analysis of cigarette
smoke from recall cigarettes did not contain a unique chemical
pattern.

Laboratory analysis of cigarettes obtained from the 72 persons
who reported illnesses is ongoing. However, as of March 22, 1996,
no unique chemical pattern had been identified.

Editorial Note from the CDC

Based on the medical records review and laboratory analyses in
this report, prolonged cigarette smoking-rather than smoking contaminated
cigarettes-caused most of the health complaints from persons reporting
illness associated with smoking Philip Morris cigarette brands
near the time of the recall. Smoking is the leading preventable
cause of diseases associated with premature death in the United
States; in 1990, approximately 419,000 deaths were attributed
to smoking. The estimated number of compounds in tobacco smoke
exceeds 4,000, including many that are pharmacologically active,
toxic, mutagenic, and carcinogenic.

Although Philip Morris reportedly recalled cigarettes, in part,
because of the recent detection of MITC, the laboratory analyses
in this report indicate that MITC was present in cigarettes manufactured
by Philip Morris up to 1 year before the recall and in cigarettes
from other manufacturers. Methyl isocyanate is a decomposition
product of 3,5-dimethyl-1,3,5,2H-tetrahydrothiadizine-2-thione,
which is used as a preservative in the manufacture and coating
of paperboard*** and as a pesticide (dazomet) that can be used
as a soil fumigant on tobacco plants, turf, and ornamental plants.
Methyl isocyanate also is a decomposition product of sodium N-methyldithiocarbamate,
a pesticide with uses similar to dazomet. Although adverse health
effects from MITC exposure (eg, mucosal irritation of the respiratory
and gastrointestinal tracts, conjunctival irritation, and neurologic
symptoms) have been documented, there have been no assessments
of the possible health effects of burned and inhaled tobacco that
contains the levels of MITC detected in this investigation or
of inhaling heated MITC found in filters.

The findings of this investigation are subject to at least four
limitations. First, reports of illness were identified by passive
surveillance; therefore, persons with health problems who contacted
the CDC may not be representative of all persons who smoked Philip
Morris cigarettes near the time of the recall and who may have
incurred related adverse effects. Second, the recalled cigarettes
provided by Philip Morris may not be representative of all the
cigarettes eligible for recall. Third, because of the protracted
time between the occurrence of clinical manifestations and the
delivery of cigarette samples to the CDC, some of the volatile
components may have evaporated from the cigarettes. Fourth, identification
of possible contaminants was complicated by lack of access to
the manufacturer's cigarette brand ingredients. Although Section
7 of the Cigarette Labeling and Advertising Act of 1996, as amended,
requires that cigarette companies annually submit to the Secretary
of the US Department of Health and Human Services confidential
lists of ingredients added to tobacco in the manufacture of cigarettes,
the law does not require companies to provide brand-specific information
about additives or information about the quantity of each additive
used in the manufacture of cigarettes. Therefore, the CDC could
not compare the standard brand ingredients with those in recalled
cigarettes; the identification of either unusual chemicals or
unusual quantities was based on comparisons between the recalled
cigarettes and samples of cigarettes produced before or after
the recall.

Other than the well-established health risks associated with smoking,
this investigation did not detect additional health problems related
to smoking cigarettes recalled by Philip Morris. Laboratory analyses
of potential contaminants in cigarettes is ongoing. However, smoking
cessation is the only effective strategy to reduce the risks associated
with cigarette smoking.